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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00391196




Registration number
NCT00391196
Ethics application status
Date submitted
19/10/2006
Date registered
23/10/2006
Date last updated
7/11/2012

Titles & IDs
Public title
A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients
Scientific title
A 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
A5351022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CP-945,598
Treatment: Drugs - CP-945,598 Treatment B

Placebo Comparator: Placebo -

Experimental: CP-945,598 -

Experimental: CP-945,598 Treatment B - Subjects receive CP-945,598 plus non-pharmacological weight loss program.


Treatment: Drugs: Placebo
Subjects receive placebo plus non-pharmacological weight loss program.

Treatment: Drugs: CP-945,598
Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Treatment: Drugs: CP-945,598 Treatment B
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change in body weight from baseline.
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Change from baseline in waist circumference at 1 year;
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Change from baseline fasting triglyceride and HDL concentrations at 1 year;
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Change from baseline in Total cholesterol, LDL, TNF a, adiponectin, and hsCRP levels at month 6 and 1 year;
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
Change from baseline fasting plasma glucose concentration at 1 year;
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
Change from baseline in Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7 scores at months 1, 2, 3, 5, 6, 9, and 1 year;
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
Timepoint [12] 0 0
1 year
Secondary outcome [13] 0 0
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
Timepoint [13] 0 0
1 year
Secondary outcome [14] 0 0
Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;
Timepoint [14] 0 0
1 year
Secondary outcome [15] 0 0
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
Timepoint [15] 0 0
1 year
Secondary outcome [16] 0 0
Waist circumference at months 3, 6, and 9;
Timepoint [16] 0 0
1 year
Secondary outcome [17] 0 0
Fasting triglyceride and HDL concentrations at month 6 and patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at months 3 and 6;
Timepoint [17] 0 0
1 year
Secondary outcome [18] 0 0
Change from baseline in laboratory tests and ECGs at 1 year; vitals signs at (at Week 2, Months 1 - 6, 9, 11 and 1 year) and adverse events;
Timepoint [18] 0 0
1 year
Secondary outcome [19] 0 0
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
Timepoint [19] 0 0
1 year
Secondary outcome [20] 0 0
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
Timepoint [20] 0 0
1 year
Secondary outcome [21] 0 0
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
Timepoint [21] 0 0
1 year
Secondary outcome [22] 0 0
Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;
Timepoint [22] 0 0
1 year
Secondary outcome [23] 0 0
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
Timepoint [23] 0 0
1 year
Secondary outcome [24] 0 0
Change from baseline HbA1c to 1 year;
Timepoint [24] 0 0
1 year

Eligibility
Key inclusion criteria
- Subjects must be overweight (BMI 27- 50 kg/m2)

- Subjects must have type 2 diabetes mellitus
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy

- Serious or unstable current or past medical conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
975
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Garran
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Kentucky
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Michigan
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Missouri
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Breclav
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Ceske Budejovice
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Olomouc
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Praha 2
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Hamburg
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Leipzig
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Germany
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Mittweida
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Cd. Madero
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DF
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Jalisco
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Nuevo León
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Banska Bystrica
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Bratislava
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Lubochna
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Nitra
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Sweden
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Goteborg
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Sweden
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Huddinge
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United Kingdom
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Lothian
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Somerset
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Coventry
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Dumfries
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Dundee
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United Kingdom
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Luton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if CP-945,598 is effective in the treatment of
obesity in type 2 diabetic patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00391196
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00391196